NCT05862831招募中1 期
Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetic and Primary Efficacy of PM1003 in Patients With Advanced Solid Tumors and Phase IIa Study to Evaluate the Primary Efficacy of PM1003 in Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 285
- 试验地点
- 2
- 主要终点
- Dose Limited Toxicity（DLT）
研究概览
简要总结
This is a single-arm, open-lable, multicenter phase I/IIa clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of PM1003 in the treatment of advanced solid tumors.
详细描述
PM1003 is a Bispecific Antibody Targeting PD-L1 and 4-1BB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
- •Male or female aged 18 to 75 years;
- •Subjects with malignant tumor confirmed by histology or cytology;
- •Adequate organ function;
- •ECOG score was 0-
- •Pre-menopausal female subjects with negative blood pregnancy results within 7 days prior to the study treatment, and agree to abstain from sex or use medically approved effective contraceptive measures for 6 months from the date of signing the informed consent form to the end of the last medication;
- •Male subjects are agree to abstain from sex or use medically approved effective contraceptive methods for 6 months from the date of signing the informed consent form to the end of the last medication, and do not donate sperm during this period.
排除标准
- •History of severe allergic to macromolecular protein drugs, severe allergy to drugs or known allergy to any component of the drug in this study;
- •Treatment with any 4-1BB monoclonal antibody or 4-1BB-containing dual antibody immune co-stimulatory molecule agonist;
- •Current active infection requiring intravenous anti-infective therapy;
- •Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
- •Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
- •History of neurological or psychiatric disorders, such as epilepsy, dementia, schizophrenia, etc.;
- •Anticipated need for any other form of antineoplastic drug treatment during the trial;
- •Women who are pregnant or breastfeeding;
- •Other conditions lead to inappropriate to participate in this study as judged by the investigator.
结局指标
主要结局
Dose Limited Toxicity（DLT）
时间窗: up to 21 days
Occurrence of DLT after receiving PM1003 injection
Assess the incidence and severity of treatment-related adverse events
时间窗: Up to 30 days after last treatment
The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) graded according to NCI-CTCAE v5.0
次要结局
未报告次要终点
研究者
研究点 (2)
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